NCT05908175

FES-assisted Gait Intervention in People with Spinal Cord Injury - Pilot Study

FES-assisted Gait Training Intervention to Improve Gait in Individuals with an Incomplete Spinal Cord Injury - a Pilot Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: Stichting Reade · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A spinal cord injury (SCI) disrupts the communication within the nervous system, leading to limitations in sensorimotor activities such as walking. Regular use of functional electrical stimulation (FES) can result in recovery of voluntary muscle control and muscle strength. Locomotor training with FES may be a promising method to improve gait function. The primary objective of this pilot study is to assess the feasibility and safety of an FES-assisted gait training intervention. Secondary objectives are to assess the effects of an FES-assisted gait training intervention on gait function.

Detailed description

A spinal cord injury (SCI) disrupts the communication within the nervous system, leading to limitations in sensorimotor activities, such as walking. These limitations are associated with muscle weakness, a disturbance of the reflex activity, and the inability or difficulty to recruit muscles below the lesion. Regular use of functional electrical stimulation (FES) can result in recovery of voluntary muscle control and muscle strength. Studies that investigated the effect of locomotor training on a treadmill with functional electrical stimulation and/or body weight support (BWS) show improved function of the lower limbs. FES-assisted gait therapy may be a promising method for improving gait function in individuals with an incomplete SCI. Therefore, this study will investigate if an FES-assisted gait (with BWS) is feasible and safe. This study will also investigfate if an FES-assisted gait can improve gait function in people with an incomplete SCI. Primary objective of this pilot study is to assess the feasibility and safety of an FES-assisted gait training intervention. The secondary objectives are to assess the effects of an FES-assisted gait training intervention on gait function.

Conditions

• Spinal Cord Injuries

Interventions

Type	Name	Description
OTHER	FES-assisted gait training	The participants will walk with functional electrical stimulation (and possible body weight support) on a treadmill for 10 weeks, twice a week for 30 minutes.

Timeline

• Start date: 2023-05-10
• Primary completion: 2024-06-07
• Completion: 2024-06-07
• First posted: 2023-06-18
• Last updated: 2024-12-18

Locations

1 site across 1 country: Netherlands